21378 Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 

applies. Federal, HHS, and CMS 

policies and standards include but are 

not limited to: all pertinent National 

Institute of Standards and Technology 

publications; the HHS Information 

Systems Program Handbook and the 

CMS Information Security Handbook. 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

STORAGE: 

Records are maintained electronically 

in the CCIIO developed database for 

collection, tracking and storage of 

casework information and for reporting 

purposes. Any manually maintained 

records will be kept in locked cabinets 

or otherwise secured areas. 

RETRIEVABILITY: 

The records are retrieved 

electronically by a variety of fields, 

including but not limited to name, State, 

zip code, and health insurance 

identification number issued to the 

individual. 

RETENTION AND DISPOSAL: 

Records are maintained with 

identifiers for all transactions after they 

are entered into the system for a period 

of 10 years. Records are housed in both 

active and archival files. All claimsrelated records are encompassed by the 

document preservation order and will 

be retained until notification is received 

from the Department of Justice. 

SYSTEM MANAGER(S) AND ADDRESS: 

Team Lead, Health Insurance 

Assistance Team, Office of Consumer 

Support, Center for Consumer 

Information and Insurance Oversight, 

Centers for Medicare and Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244. 

NOTIFICATION PROCEDURE: 

For purpose of notification, the 

subject individual should write to the 

system manager who will require the 

system name and the retrieval selection 

criteria (e.g., name, health insurance 

claim number, SSN, etc.). 

RECORD ACCESS PROCEDURE: 

For purpose of access, use the same 

procedures outlined in Notification 

Procedures above. Requestors should 

also reasonably specify the record 

contents being sought. (These 

procedures are in accordance with 

Department regulation 45 CFR 

5b.5(a)(2)). 

CONTESTING RECORD PROCEDURES: 

The subject individual should contact 

the system manager named above, and 

reasonably identify the record and 

specify the information to be contested. 

State the corrective action sought and 

the reasons for the correction with 

supporting justification. (These 

procedures are in accordance with 

Department regulation 45 CFR 5b.7). 

RECORD SOURCE CATEGORIES: 

The identifying information contained 

in these records is provided voluntarily 

by the individual consumers, 

confidential informants, or by reports 

received from other sources . Additional 

case-relevant information may also be 

provided by the individual’s employer 

or insurer to assist in achieving 

resolution of the specific case. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

[FR Doc. 2011–9105 Filed 4–14–11; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0264] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Request for 

Designation as Country Not Subject to 

the Restrictions Applicable to Human 

Food and Cosmetics Manufactured 

From, Processed With, or Otherwise 

Containing, Material From Cattle 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection provisions of 

existing FDA regulations regarding 

countries seeking to be designated as 

not subject to certain bovine spongiform 

encephalopathy (BSE)-related 

restrictions applicable to FDA-regulated 

human food and cosmetics. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 14, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal Agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 21379 

Request for Designation as Country Not 

Subject to the Restrictions Applicable to 

Human Food and Cosmetics 

Manufactured From, Processed With, or 

Otherwise Containing, Material From 

Cattle—21 CFR 189.5 and 700.27 (OMB 

Control Number 0910–0623—Extension) 

Section 801(a) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 381(a)) provides requirements 

with regard to imported food and 

cosmetics and provides for refusal of 

admission into the United States of 

human food and cosmetics that appear 

to be adulterated. Section 701(b) of the 

FD&C Act (21 U.S.C. 371(b)) authorizes 

the Secretaries of Treasury and Health 

and Human Services to jointly prescribe 

regulations for the efficient enforcement 

of section 801 of the FD&C Act. To 

address the potential risk of BSE in 

human food and cosmetics, FDA 

regulations in §§ 189.5 and 700.27 (21 

CFR 189.5 and 700.27) designate certain 

materials from cattle as ‘‘prohibited 

cattle materials,’’ including specified 

risk materials, the small intestine of 

cattle not otherwise excluded from 

being a prohibited cattle material, 

material from nonambulatory disabled 

cattle, and mechanically separated (MS) 

(Beef). Under the regulations no human 

food or cosmetic may be manufactured 

from, processed with, or otherwise 

contain prohibited cattle materials. 

However, the Agency may designate a 

country from which cattle materials 

inspected and passed for human 

consumption are not considered 

prohibited cattle materials and their use 

does not render a human food or 

cosmetic adulterated. 

Sections 189.5(e) and 700.27(e) 

provide that a country seeking to be so 

designated must send a written request 

to the Director, Center for Food Safety 

and Applied Nutrition (CFSAN). The 

information the country is required to 

submit includes information about a 

country’s BSE case history, risk factors, 

measures to prevent the introduction 

and transmission of BSE, and other 

information relevant to determining 

whether specified risk materials, the 

small intestine of cattle not otherwise 

excluded from being a prohibited cattle 

material, material from nonambulatory 

disabled cattle, or MS (Beef) from the 

country seeking designation should be 

considered prohibited cattle materials. 

FDA uses the information to determine 

whether to grant a request for 

designation, and whether to impose 

conditions if a request is granted. 

Sections 189.5 and 700.27 further 

state that countries that have been 

designated under §§ 189.5(e) and 

700.27(e) will be subject to future 

review by FDA to determine whether 

designation remains appropriate. As 

part of this process, FDA may ask 

designated countries to confirm that 

their BSE situation and the information 

submitted by them in support of their 

original application remain unchanged. 

FDA may revoke a country’s designation 

if FDA determines that it is no longer 

appropriate. Therefore, designated 

countries may respond to periodic 

requests by FDA by submitting 

information to confirm that their 

designation remains appropriate. FDA 

uses the information to ensure that their 

designation remains appropriate. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

§§ 189.5 and 700.27— request for designation 1 1 1 80 80 

§§ 189.5(e) and 700.27(e)—response to request for review by FDA .............................. 1 1 1 26 26 

Total .......................................................... ............................ ............................ ............................ ............................ 106 

1 There are no capital costs or operating and maintenance costs associated with this collection of information. 

This estimate is based on FDA’s 

experience and the average number of 

requests for designation under §§ 189.5 

and 700.27 received in the past 3 years. 

FDA received one request for 

designation in 2009 and one in 2010. 

Based on this experience, FDA estimates 

the annual number of new requests for 

designation will be 1. FDA estimates 

that preparing the information required 

by §§ 189.5 and 700.27 and submitting 

it to the Agency in the form of a written 

request to the Director, CFSAN will 

require a burden of approximately 80 

hours per request. Thus, the annual 

burden for new requests for designation 

is estimated to be 80 hours, as shown in 

table 1, row 1 of this document. 

Under §§ 189.5(e) and 700.27(e), 

designated countries are subject to 

future review by FDA and may respond 

to periodic requests by FDA by 

submitting information to confirm that 

their designation remains appropriate. 

In the last 3 years, FDA has not 

requested any reviews. Thus, the 

Agency estimates that one or fewer will 

occur annually in the future. We 

estimate that the designated country 

undergoing a review in the future will 

need one third the time it took 

preparing its request for designation to 

respond to FDA’s request for review, or 

26 hours (80 hours x 0.33 = 26.4 hours, 

rounded to 26). The annual burden for 

reviews is estimated to be 26 hours, as 

shown in table 1, row 2 of this 

document. The total annual burden for 

this information collection is estimated 

to be 106 hours. 

Dated: April 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9154 Filed 4–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0263] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experiment To 

Evaluate Risk Perceptions of Produce 

Growers, Food Retailers, and 

Consumers After a Food Recall 

Resulting From a Foodborne Illness 

Outbreak 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 


srobinson on DSKHWCL6B1PROD with NOTICES